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US20020035373A1 - System and method for establishing vascular access - Google Patents

System and method for establishing vascular access Download PDF

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Publication number
US20020035373A1
US20020035373A1 US09/994,980 US99498001A US2002035373A1 US 20020035373 A1 US20020035373 A1 US 20020035373A1 US 99498001 A US99498001 A US 99498001A US 2002035373 A1 US2002035373 A1 US 2002035373A1
Authority
US
United States
Prior art keywords
sleeve
guidewire
dilator
diameter
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US09/994,980
Other languages
English (en)
Inventor
John Carlson
Craig Tsuji
Scott Harris
Michael Orth
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien LP
Original Assignee
Innerdyne Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innerdyne Inc filed Critical Innerdyne Inc
Priority to US09/994,980 priority Critical patent/US20020035373A1/en
Publication of US20020035373A1 publication Critical patent/US20020035373A1/en
Priority to US11/175,656 priority patent/US20050245959A1/en
Priority to US11/175,655 priority patent/US20050245958A1/en
Assigned to TYCO HEALTHCARE GROUP LP reassignment TYCO HEALTHCARE GROUP LP ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: INNERDYNE, INCORPORATED
Assigned to INNERDYNE, INC. reassignment INNERDYNE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CARLSON, JOHN E., HARRIS, SCOTT L, ORTH, MICHAEL J., TSUJI, CRAIG K
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3431Cannulas being collapsible, e.g. made of thin flexible material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024Expandable catheters or sheaths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Definitions

  • the present invention relates generally to medical devices and medical methods.
  • the present invention relates to systems, kits, and techniques for establishing percutaneous vascular access.
  • Access to patient blood vessels is necessary for a wide variety of diagnostic and therapeutic purposes.
  • intravascular catheters are introduced to both the arterial vasculature and the venous vasculature, typically using either surgical cut down techniques or percutaneous introduction techniques.
  • the most common percutaneous introduction technique is referred to as the Seldinger technique.
  • the basic Seldinger technique relies on initially accessing a target blood vessel with a needle. A guidewire is then passed through the needle into the blood vessel, and the needle withdrawn over the guidewire. A dilator is then passed over a guidewire to enlarge the diameter of the tissue tract so that it can accommodate a larger introducer sheath. Once the introducer sheath is in place, access to the blood vessel can be reliably obtained through a lumen of the sheath.
  • the present invention provides improved systems, kits, and methods for establishing percutaneous access to a patient's vasculature.
  • Access can be established to a variety of particular blood vessels, including both arteries and veins, such as the femoral artery, radial artery, and the like.
  • the purpose for accessing the vasculature can be diagnostic, such as angiography, intravascular ultrasound, cardiac mapping, or the like, or can be therapeutic, such as angioplasty, atherectomy, minimally invasive cardiac surgeries, endovascular aneurysm repair, cardiac ablation, or the like.
  • the methods of the present invention comprise particular improvements over the Seldinger technique, as described above, employing a sheath dilator for expanding an initial needle penetration to a target blood vessel.
  • a dilator/sheath assembly directly within a tissue tract can subject the tissue to significant axial forces which can delaminate or otherwise damage the tissue surrounding the tissue tract.
  • the present invention reduces the risk of injuring the tissue by introducing a radially expandable sleeve over a guidewire which has been placed through the tissue tract using otherwise conventional techniques.
  • the radially expandable sleeve will be immobilized (typically being manually held) relative to the tissue tract so that axial advancement of a sheath/dilator or other dilating member through the radially expandable sleeve will impart little or no axial force to the underlying tissue. Instead, only radially expansive forces will be transmitted outwardly through the sleeve.
  • Systems according to the present invention for establishing vascular access over a guidewire comprise a dilator and a radially expandable sleeve.
  • the dilator has a lumen sized to be introduced over the guidewire.
  • the guidewire will have a pre-selected diameter which is generally constant over its entire length. The diameter will be relatively small, typically being either 0.36 mm (0.014 in.) or 0.89 mm (0.035 in.), which are conventional sizes for guidewires used for vascular access.
  • the lumen of the dilator will be sized slightly greater than the outside diameter of the guidewire with which it is to be used, typically being 0.46 mm (0.018 in.) or 1 mm (0.4 in.) for each of the guidewire sizes mentioned above.
  • the dilator will have an outside diameter selected to provide for a desired degree of radial expansion of the tissue tract.
  • the outside diameter of the dilator will be in the range from 1 mm to 2.5 mm for the smaller guidewire size and 1.3 mm to 3.3 mm for the larger guidewire size.
  • the radially expandable sleeve will have a lumen therethrough and an unexpanded diameter which is only slightly greater than the diameter of the associated guidewire, e.g., 0.41 mm (0.016 in.) for the 0.36 mm (0.014 in.) guidewire and 0.96 mm (0.038 in.) for the 0.89 mm (0.035 in.) guidewire.
  • the sleeve will have an outside diameter which is no more than 300% of the guidewire diameter, preferably being no more than 200% of the guidewire diameter.
  • the sleeve will have an expandable outer wall which permits the dilator to be introduced over the guidewire and through the sleeve to cause expansion.
  • the outer wall of the radially expandable sleeve can be compliant or elastic so that its cross-section collapses after expansion if the dilator used for expansion is withdrawn.
  • the compliant or elastic structure will be reinforced with a tubular braid, e.g., a braid formed as a mesh of non-elastic filaments where radial expansion will cause axial shortening of the braid.
  • the braid may be embedded in the elastic or compliant layer or may be covered by the elastic or compliant layer.
  • the radially expandable sleeve may have a plastically deformable body or may comprise a locking structure so that it retains its expanded diameter after dilation.
  • the plastically deformable radially expandable sleeves will also be reinforced with the braid.
  • the braid may be covered or impregnated with a suitable plastically deformable material, such as expanded PTFE, irradiated polyesters, and the like.
  • the braid reinforcement may be configured so that the braid filaments interlock upon radial expansion. Thus, the filaments in themselves will resist radial collapse after the sleeve has been expanded.
  • the system may further comprise a sleeve introducer adapted to facilitate introduction of the sleeve over a guidewire through the tissue tract.
  • a sleeve introducer adapted to facilitate introduction of the sleeve over a guidewire through the tissue tract.
  • conventional Seldinger and other access techniques can be difficult due the presence of scar tissue or other complicating factors.
  • significant pushing force may be required to advance the sleeve over the guidewire.
  • the small profile of the introducer sleeve reduces the force necessary for introduction over the guidewire, in some cases it will be desirable to still further reduce the introduction force.
  • Such a reduction in introduction force can be accomplished by providing a tapered distal tip on the sleeve.
  • a separate introducer sleeve having a tapered distal end a lumen therethrough.
  • the sleeve is configured to receive a guidewire through its lumen and to be received within the lumen of the radially expandable sleeve.
  • the temporary assembly of the sleeve and sleeve introducer can be introduced over the guidewire so that the tapered end of the sleeve introducer first advances through and dilates the tissue tract to reduce the necessary introduction force.
  • the dilator may then be introduced over the assembly, i.e., the lumen of the dilator will pass over the exterior of the sleeve introducer. After dilation of the radially expansible sleeve is accomplished, the sleeve introducer and guidewire can then be removed from the expanded access channel defined by the dilator.
  • Methods according to the present invention for establishing vascular access comprise forming a percutaneous tissue tract to a target blood vessel.
  • the tissue tract is initially formed using a needle and guidewire according to conventional techniques, such as the first steps in a Seldinger access protocol.
  • a guidewire is positioned in the tissue tract, and a radially expandable sleeve positioned over the guidewire and through the tissue tract so that a distal end of the sleeve lies in the blood vessel.
  • a proximal end of the sleeve will remain outside the tissue tract, and the sleeve may then be expanded from a narrow diameter configuration to a larger diameter configuration to provide an access lumen to the blood vessel.
  • the sleeve will be plastically deformable or otherwise capable of maintaining its larger diameter configuration, and expansion can be effected using a simple dilator without an associated sheath.
  • the radially expandable sleeve will be elastic or compliant and expansion can be effected using a sheath dilator where the dilator is removed after expansion and the sheath left in place to maintain the desired access lumen.
  • the radially expandable sleeve which is advanced over the guidewire will have an outer diameter which is no more than 300% larger than the guidewire diameter, preferably no more than 200% larger.
  • kits for performing any of the methods described herein.
  • the kits will comprise at least a radially expandable sleeve together with instructions setting forth a method according to the present invention.
  • the kits will further comprise a dilator and optionally still further comprise a guidewire.
  • the dilator may be a simple dilator with no associated access sheath when the radially expandable sleeve is plastically deformable or otherwise capable of maintaining its expanded diameter configuration.
  • the dilator can be a conventional sheath/dilator combination when the radially expandable sleeve is elastic or compliant.
  • FIG. 1 illustrates a system comprising a radially expandable sleeve, a dilator, and a guidewire, according to the present invention.
  • FIGS. 2 A- 2 E illustrate use of the system of FIG. 1 for establishing vascular access to a target blood vessel according to a method of the present invention.
  • FIG. 3 illustrates a sleeve introducer which may combined in an assembly with a radially expandable sleeve and optionally a guidewire according to the systems and methods of the present invention.
  • FIGS. 4 A- 4 C illustrate use of the sleeve introducer assembly of FIG. 3 in the methods of the present invention.
  • FIG. 5 illustrates a kit constructed in accordance with the principles of the present invention.
  • a system 10 for establishing vascular access comprises a radially expandable sleeve 12 , a dilator 14 , and a guidewire 16 .
  • the radially expandable sleeve comprises a radially expandable tubular body having a proximal end, a distal end, and an axial lumen extending from the proximal end to the distal end.
  • a handle 20 is provided at the proximal end of the body so that the sleeve can be manually held during use, e.g., tension can be applied on the handle as the dilator 14 is passed through the body of the sleeve as described in more detail below.
  • the radially expandable sleeve 12 may have a compliant or elastic structure which permits expansion from an initial small diameter (radially collapsed) configuration to a larger diameter configuration which is caused by introduction of the dilator therethrough.
  • Use of the compliant or elastic sleeve will require a separate component for maintaining the expanded diameter of the tissue tract, as described in more detail below.
  • the radially expandable sleeve can have a plastic or other locking structure so that, once expanded, it will retain its large diameter configuration without the need for using other supports, devices, or the like.
  • An exemplary radially expandable sleeve comprises an expandable tubular braid which is initially an elongated, narrow-diameter configuration.
  • the braid may be open, but will usually be laminated or covered with a coating or layer of elastic or plastically deformable material, such as silicone rubber, latex, polyethylene, C-flex, or the like.
  • the braid is preferably formed as a mesh of individual non-elastic filaments, such as polyamide fibers, stainless steel, or the like.
  • Exemplary sleeve diameters have been set forth above. Usually, the sleeve will have a length in the range from 3 cm to 30 cm, more usually from 10 cm to 25 cm. The exact dimensions of the sleeve will intend on the desired use and location of the target blood vessel to be accessed.
  • a dilator 14 may be a simple dilator having a tapered distal end and smooth transition to a uniform body diameter.
  • the dilator will have a guidewire lumen to permit introduction over the guidewire and through the radially expandable sleeve, as described in more detail below.
  • dilator 14 is in the form of a conventional sheath/dilator assembly of the type which is commercially available from vendors, such as Bard Cardiology, Billerica, Mass., under the trade name InputTM.
  • the dilator/sheath assembly includes an outer sheath 30 with an inner tapered dilator 32 which is removable from the sheath.
  • the sheath has a hemostatic valve 34 at its distal end and a side access tube 36 which permits perfusion or aspiration through the lumen of the sheath.
  • the dilator 32 has a handle 38 at its proximal end and an internal lumen which permits introduction over the guidewire 16 .
  • the guidewire 16 may be a conventional vascular access guidewire, typically having a diameter of either 0.36 mm (0.014 in.) or 0.89 mm (0.035 in.), and a length in the range from 35 cm to 100 cm.
  • FIGS. 2 A- 2 E use of the system 10 for accessing a blood vessel BV will be described.
  • an initial tissue tract is formed using a needle N and syringe S assembly as shown in FIG. 2A.
  • the syringe may be removed and a guidewire GW placed through the needle into the blood vessel BV.
  • the needle N may then be withdrawn over the proximal end of the guidewire GW, leaving the guidewire in place through a tissue tract TT, as illustrated in FIG. 2B.
  • the radially expandable sleeve 12 is then introduced over the guidewire GW so that its distal end 13 lies within the blood vessel BV, as shown in FIG. 2C.
  • the dilator 14 is then introduced over the guidewire GW so that the distal end of the dilator 14 causes radial expansion of the sleeve 12 , as shown in FIG. 2D.
  • an inner dilator portion 32 may be withdrawn from the sheath 30 , leaving the sheath in place through the radially expandable sleeve 12 , both being over the guidewire GW, as shown in FIG. 2E.
  • Vascular access has now been established for performing any one of a wide variety of diagnostic or therapeutic procedures as well described in the medical and patent literature.
  • a sleeve introducer 50 may be combined with a radially expandable sleeve 52 and optionally a guidewire 54 to form an expansible sleeve assembly intended for introduction through difficult tissue tracts, i.e., tissue tracts which might otherwise require excessive pushing force to introduce a sleeve according to the methods of the present invention.
  • the sleeve introducer 50 comprises a tapered distal end 60 , typically a conical element having a smaller diameter at its distal end and a larger diameter at its proximal end.
  • the introducer 50 further comprises a shaft 62 extending proximally from the tapered distal end 60 .
  • the shaft will be a small tube, and the distal end 60 and shaft 62 together define a lumen which may be introduced over the guidewire 54 .
  • the outer diameter of the shaft 62 is selected so that it fits within the inner diameter of radially expandable sleeve 52 .
  • the proximal end of the tapered distal end 60 will have a diameter which is the same as the outer diameter of the distal end 66 of the radially expandable sleeve 52 .
  • the sleeve introducer 50 may be placed within the lumen of the radially expandable sleeve 52 to form an assembly having a tapered distal end which facilitates introduction over the guidewire 54 .
  • FIGS. 4 A- 4 C use of the assembly of FIG. 3 for dilating the tissue tract to a blood vessel BV will be described.
  • the guidewire 54 is first placed into the blood vessel BV, typically using a needle as described above in connection in FIG. 3A.
  • the guidewire 54 used for more difficult introductions will have a slightly smaller diameter than would otherwise be necessary, such as a diameter of about 0.6 mm (0.025 in.).
  • the assembly of the sleeve introducer 50 and radially expandable sleeve 52 is then introduced over the guidewire, with the guidewire passing directly through the lumen of the introducer 50 .
  • the tapered distal end 60 of the introducer 50 thus leads the way through the tissue over the guidewire 54 , so that the taper facilitates passage of the assembly through the tissue.
  • a dilator 30 having an inner portion 32 may be introduced directly over the exterior of the sleeve introducer 50 , as shown in FIG. 4C.
  • the combination of the sleeve introducer 50 and guidewire 54 may be withdrawn, leaving the inner diameter of the inner dilator portion 32 available for expanded access to the blood vessel BV.
  • kits according to the present invention will comprise at least a radially expandable sleeve 12 together with instructions for use IFU setting forth a method according to the principles of the present invention.
  • a dilator 14 ′ will also be included in the kit.
  • the dilator 14 ′ is shown as a simple dilator without an associated access sheath. Such a dilator is suitable for use with a plastically deformable radially expandable sleeve.
  • the kits may optionally further comprise a guidewire GW, a sleeve introducer 50 , and/or a needle N and all kit components will typically be packaged together in a box, tray, tube, pouch, or other conventional medical device package P.
  • kit components which are employed in the medical procedure will typically be maintained within sterile packaging, with individual components being packaged either together or separately in different sterile containers. Usually, even when packaged in separate sterile containers, all components of the kit will be placed together within a common package.
  • the instructions for use may be provided on a separate printed sheet, such as a conventional package insert, or may be printed in whole or in part on other portions of the packaging or the device itself.

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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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US09/994,980 1999-05-19 2001-11-27 System and method for establishing vascular access Abandoned US20020035373A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US09/994,980 US20020035373A1 (en) 1999-05-19 2001-11-27 System and method for establishing vascular access
US11/175,656 US20050245959A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access
US11/175,655 US20050245958A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31487899A 1999-05-19 1999-05-19
US09/994,980 US20020035373A1 (en) 1999-05-19 2001-11-27 System and method for establishing vascular access

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US31487899A Continuation 1999-05-19 1999-05-19

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US11/175,655 Continuation US20050245958A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access
US11/175,656 Division US20050245959A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access

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US20020035373A1 true US20020035373A1 (en) 2002-03-21

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US09/994,980 Abandoned US20020035373A1 (en) 1999-05-19 2001-11-27 System and method for establishing vascular access
US11/175,655 Abandoned US20050245958A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access
US11/175,656 Abandoned US20050245959A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access

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US11/175,656 Abandoned US20050245959A1 (en) 1999-05-19 2005-07-06 System and method for establishing vascular access

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US (3) US20020035373A1 (fr)
EP (1) EP1194074A4 (fr)
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US11812980B2 (en) 2017-11-09 2023-11-14 Stryker Corporation Inverting thrombectomy apparatuses having enhanced tracking
US11896247B2 (en) 2016-04-25 2024-02-13 Stryker Corporation Inverting mechanical thrombectomy apparatuses
US11896251B2 (en) 2018-05-14 2024-02-13 Stryker Corporation Inverting thrombectomy apparatuses and methods of use
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JP4406668B2 (ja) 2010-02-03
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US20050245959A1 (en) 2005-11-03
WO2000069350A1 (fr) 2000-11-23
JP4225697B2 (ja) 2009-02-18
EP1194074A4 (fr) 2002-09-11
EP1194074A1 (fr) 2002-04-10
JP2002543914A (ja) 2002-12-24

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